Cholesterol-lowering medications, commonly
referred to as statins, are considered so
beneficial that some enthusiastic doctors
declare, “they should be put into the drinking
water.” The pharmaceutical companies and their
sales staff (most medical doctors) would like
you to believe that simply lowering your
cholesterol number is the major solution to your
health problems. And that is untrue.

Statin medications inhibit the activity
of an enzyme involved in the production
of cholesterol in the liver. The name of
the enzyme is
3-hydroxy-3-methylglutaryl-coenyzme A
reductase. Thus the drugs are called
HMG-CoA reductase inhibitors—or a much
easier name, statins.
When this enzyme is blocked, the liver
makes less cholesterol and the blood
levels of cholesterol fall.

Statins do reduce
cholesterol measured in the blood, but what is
unclear is the real benefit for the patient—will
the patient live longer and/or healthier? Or
will he or she simply have a fatal heart attack
the same day (as would have occurred without the
medication), but with a lower blood cholesterol
level? The decision to take these medications
should not be made lightly. This is a lifetime
commitment and for a young person this could
mean 50 years of drug-therapy with the potential
of serious side effects at a cost of more than
$1000 per year.

No One Dies of
High Cholesterol

During my forty
years of medical practice, I have never seen
anyone die of high cholesterol (and neither has
any other doctor). Cholesterol is a risk
factor—this means it is a sign that reflects:
the richness of the person’s diet, his or her
ability to metabolize the rich foods, and most
importantly, the overall health of the body. The
cholesterol molecules, themselves, in the
bloodstream are relatively non-toxic. If
cholesterol, itself, were the problem, then
their predictive value for heart attacks and
strokes would be close to 100% —high cholesterol
would always mean sick arteries. However, I
know many people with cholesterol levels over
300 mg/dL, with perfectly clean arteries—and
just the opposite, people with levels below 170
mg/dL who have suffered a major heart attack.
Furthermore, when the arteries of patients
taking statins are studied over time, regression
of the underlying artery disease,
atherosclerosis, occurs in only a minority of
patients, even if cholesterol drops profoundly
under the influence of powerful medications.

The underlying
truth is: there is a strong correlation between
the richness of a person’s diet (reflected by
cholesterol and saturated fat content of the
food choices) and the level of cholesterol found
in that person’s blood. The richer the diet,
the higher the blood cholesterol. The
association continues: the higher the
cholesterol in the diet and in the blood, the
more likely disease will happen—such as heart
attacks, strokes, and a variety of cancers. The
real culprit is the rich diet—the elevated
cholesterol is, more or less, a secondary
finding.

Because of the
enthusiastic and dishonest promotion of these
high profit drugs, many patients actually
believe they are “cured” of their health
problems—as a result they may see no more need
to make beneficial diet and lifestyle changes,
which in truth make a far greater difference
than any medications. One recent analysis found
smoking cessation and the use of plain aspirin
to be much more cost-effective than the
prescription statins.1

High Risk
Patients Show the Greatest Benefits

Patients with the
greatest risk of a future tragedy should receive
the most intensive treatment with diet and/or
medications, because they will experience the
greatest benefits with reduction of heart
attacks and strokes, at the most reasonable
costs.

The risk of future
tragedies is predicted by observing signs,
called risk factors. These include high blood
pressure, cholesterol, triglycerides, uric acid,
and blood sugar, as well as, being overweight.
Information on family history, alcohol use,
exercise, and smoking is also important. An
even more reliable predictor of future problems
is a person’s history of having problems with
his or her arteries. Thus, people with a history
of a heart attack, stroke, bypass surgery,
and/or angioplasty are at the highest risk and
the ones most likely to benefit from statin
therapy.

Increasing the
Market by Disease Mongering

When I started in
medicine in the 1970s, a high cholesterol level
was considered to be above 350 mg/dL. The
pharmaceutical industries were in their infancy
and the primary medications for lowering
cholesterol were the low-profit vitamins,
niacin, and cholesterol binding agents. These
drugs also had disturbing side effects like
flushing (niacin) and constipation (binding
agents). Using this definition (350 mg/dL or
greater) there was only a small market for
cholesterol-lowering medications.

By no coincidence,
with the discovery and popularization of
high-profit statins over the past two decades,
the definition of high cholesterol has fallen so
that anyone with a cholesterol level above 200
mg/dL is abnormal. Over half the people
following the Western diet are now potential
customers for statins by this definition.
Lately, expert opinions have suggested that
ideal cholesterol would be below 150 mg/dL.
That means, almost everybody needs to be on
statins—we might as well put these drugs in the
drinking water.

Most Women
Should Avoid Statins

General agreement
among doctors is that people at low risk should
not be taking statins. Women, especially before
menopause, have a much lower risk of developing
heart disease, than do men of a similar age. To
date, none of the large trials involving women
who already have heart disease (secondary
prevention) has shown a reduction in overall
mortality in women from using statins.2
For women who have never had heart disease
(primary prevention), trials have
shown neither an overall reduction in death
(mortality benefit), or a reductionin heart attacks or surgery. One
meta-analysis suggested that overall mortality
may actually be increased by1% over
10 years in both men and women.2

Muscle Damage
from Statins

Most medical
doctors think statins have few side effects—and
that these are mild and reversible. Complaints
by patients on statins are often dismissed by
their doctors as unrelated to the medication,
and the issue of side effects has not been well
studied, therefore, the true incidence is
unknown. (See below for common side effects.)

The most serious
adverse effect of taking these medications is
damage to the muscles, called rhabdomyolysis,
which can occasionally result in death. An
estimated 1% to 5% of people on these
medications experience muscle inflammation and
pain (myositis). The more potent the statins;
the greater the risk of muscle damage. A recent
study, with electron microscopy and biochemical
approaches, examined the muscle tissues of
patients on statins. They found muscle cell
damage in over 70% of people on statins, even
when they had no complaints of pain.3

Relative Potency of Statins and Risk of
Muscle Damage4

Potency*

Fatal
Rhabdomyolysis**

Fluvastatin (Lescol)

1

0

Pravastatin (Pravachol)

2

.04

Lovastatin
(Mevacor)

3

.19

Simvastatin (Zocor)

6

.12

Atorvastatin (Lipitor)

12

.04

Cerivastatin (Crestor)

200

3.16

*Relative potency of 60 mg daily, with
Fluvastatin equal to 1
** Cases per million prescriptions

Alternatives
Medications to Statins

There are also
alternative cholesterol-lowering medications,
such as time-honored niacin and a
cholesterol-binding agent (Colestid, Questran,
and Welchol), which have been used since I
started practice and have benefits equal to
statins (which are limited as we have
discussed).

There are also
newer medications recently introduced, like
Zetia and Tricor. No doubt they lower
cholesterol, but life-saving and
health-improving benefits have not been
demonstrated. (See below for a more complete
description of cholesterol-lowering
medications.

There are several
“natural” cholesterol-lowering medications that
according to published studies lower
cholesterol. The ones I use most often are
garlic, oat bran, vitamin C, and gugulipid. (I
no longer use vitamin E because studies show it
increases heart disease and death.5)
Because of the low cost, and minimal side
effects I recommend these often. However, my
experience has been that few patients attain a
substantial reduction in cholesterol by this
approach. Therefore, when I feel the indication
to lower cholesterol is clear, I resort to
prescription medications. (More information on
these "natural"
cholesterol-lowering medications can be
found in my September 2002 newsletter.)

I Do Prescribe
Statins and I Hope I Guess Right

As a medical
doctor I am obliged to offer every one of my
patients the best care possible, based on the
best evidence available. Unfortunately, most of
that evidence on the efficacy of medications has
been heavily tainted by pharmaceutical
companies—so the truth is hard for me to know.
Based on current published research, I try to do
the best for my patients, but I reserve the
right to change my opinion on any drug I use.

I see many people
with elevated cholesterol levels who also have a
past history of heart disease—heart attacks,
angioplasty and bypass surgery—and some with
strokes. I usually offer these high risk
patients the statins. But, I always qualify my
prescription by telling them that I am only
guessing (and hoping) that I will be doing them
more good than harm. My guess is educated
because I have been practicing (a descriptive
word) for about 40 years and I have read and
understand most of the research on this
subject. Thus, I would not make the offer if I
did not believe it to be correct.

I also make it
clear that since I am offering only my best
guess, that the patient must be involved in the
decision. Some people are very uncomfortable
about having a high cholesterol level regardless
of how much I try to reassure them that I
believe they are in good health and at very low
risk of a problem. Others fear the drugs, and
would take almost any risk to avoid them. My
decision to write a prescription weighs heavily
on each person’s feelings.

When I believe the
situation warrants aggressive treatment, one of
my goals is to lower total cholesterol below 150
mg/dL. The LDL-cholesterol should be below 80
mg/dL.

Possible Scenarios with Cholesterol
above 200 mg/dL

A 60
year-old woman who is trim, exercises
daily, does not smoke, and has no family
history of heart disease = no
cholesterol-lowering medication.

A 50
year-old overweight man with diabetes,
no exercise and is unable to change his
diet = yes, cholesterol-lowering
medication.

A 45
year-old overweight man who has decided
to make serious diet and lifestyle
changes, and also hates to take drugs =
no cholesterol-lowering medication.

A 75
year-old woman who is going to follow
the diet and exercise, but has a
premonition that she is going to die of
heart disease and insists on the
medication = yes, cholesterol-lowering
medication.

A 65
year-old man with a recent history of an
angioplasty, who took statins, but
developed muscle pains = yes,
cholesterol-lowering medication, like
niacin and Colestid, but no statins.

In these
cases other decisions can be easily
justified, but with little supporting
evidence.

Preferred
Statin?

Some statins are
able to cross cell membranes easily—they are
referred to as the fat-soluble statins (also
hydrophobic and lipophilic statins). These
include lovastatin, simvastatin, fluvastatin,
and atorvastatin. There is concern that these
fat-soluble statins may enter the cell and
interfere with various substances essential for
cell function, thus reducing their lifesaving
benefits.6

All statins lower
total cholesterol and LDL-cholesterol, and
sometimes they show a small reversal of
atherosclerosis. But the fat-soluble statins,
in one recent review, showed less reduction of
cardiac events (heart attacks, angioplasty,
bypass surgery, sudden death, and overall
mortality) than did a statin that is not fat
soluble (and enters the cells less readily),
called pravastatin (Pravachol).6 The
primary goal of treatment is to reduce
life-damaging events (not just lower
cholesterol).

Based on this
paper6 and the fact that pravastatin
is generic (less costly), I am inclined to
prescribe this variety over the others. (Most
statins sell for the same price for a pill
regardless of the strength; eg. 80 mg, 40 mg, 20
mg. To cut costs even further, tablets—except
for time-release tablets—can be split in half.)

How Long Should
Patients Take Cholesterol-lowering Drugs?

When the
medications are stopped the cholesterol
rises—usually to pretreatment levels. So once
you are on these medications, you may be on for
life; unless you make serious dietary and
lifestyle changes. With a change in diet, not
only does the cholesterol drop, but the artery
disease heals. This is referred to as
“reversal,” and can be seen in 82% of people
by the first year.7 After the
first year, the benefits continue with even more
reversal and healing seen. Dean Ornish, MD,
says, “According to the PET scans, 99% of the
patients stopped or reversed the progression of
coronary heart disease.”8

The decision as to
when to stop taking statins is based again on
guess work. If the patient with a past history
of heart artery disease has made remarkable
improvements in health through diet and exercise
(reflected in weight loss, vigor, blood pressure
and other risk factors, improved feelings of
well-being, etc.), then my guess is one to five
years of cholesterol-lowering therapy may be
enough. To help with this decision, I check
cholesterol levels after the medications are
stopped. If the cholesterol level remains below
150 mg/dl without medication, I feel even more
confident that the patient will do well (another
guess).

The Diet Is
Forever

A no-cholesterol,
low-fat diet (The McDougall Diet) is the first
step to lowering elevated cholesterol and
cleaning out the arteries. You can expect a
reduction in cholesterol by 20% to 45% with
strict adherence. In general, the higher the
initial level the greater the reduction after a
change in diet. There are no side effects to
this approach, and most people reduce their food
bills by 40% or more (especially those in the
habit of eating out). Plus, this is the same
diet that benefits the rest of the body by
causing loss of excess weight, relieving aches
and pains, regulating bowel function, lowering
other common risk factors (blood pressure, blood
sugar, triglycerides, etc.), and reducing the
risk of future diseases and prolonging life—what
a deal! If only money could be made from you
changing your diet!

Regardless of the
patient’s chances of benefits and risk from
medications, diet and lifestyle changes should
be the first and most enthusiastic prescription
made by all doctors for their patients. Only
then, as a last resort, the patient and the
doctor should look into medications.

Common Prescription
Cholesterol-lowering Medications

It's important to
remember that medications are a
supplement to--not a substitute
for--diet, exercise, and weight loss.
Medications are even more effective when
combined with a no-cholesterol, low-fat
diet.

Statins:

Warnings and side
effects: Never take statins during
pregnancy or while breastfeeding. You
should also avoid statins if you have
liver disease, or if the drug gives you
an allergic reaction. Common side effect
include abdominal pain, abnormal
heartbeat, accidental injury, allergic
reaction, arthritis, back pain,
bronchitis, chest pain, constipation,
diarrhea, dizziness, flu symptoms, fluid
retention, gas, headache, indigestion,
infection, inflammation of sinus and
nasal passages, insomnia, joint pain,
muscle aching or weakness, nausea, rash,
stomach pain, urinary tract infection,
and weakness.

Advicor: a combination of
extended-release niacin and lovastatin (Mevacor)

Altocor: an
extended-release form of the
cholesterol-lowering drug lovastatin,
which releases small amounts of the drug
throughout the day

Altoprev: an
extended-release form of the
cholesterol-lowering drug lovastatin,
which releases small amounts of the drug
throughout the day

Colestid (colestipol),
Questran and Questran Light (cholestyramine
resin), and Welchol (colesevelam
hydrochloride): cholesterol binding
agents, also referred to as a bile acid
sequestrant because they work by binding
with cholesterol-based bile acids and
take them out of circulation. This
prompts the liver to produce a
replacement supply of bile acids,
drawing the extra cholesterol it needs
out of the bloodstream. More common
side effects may include: constipation,
indigestion, muscle aches, sore throat,
and weakness. Because they inhibit the
absorption of other medications they
should not be taken at the same time.

Niaspan (niacin 500mg
extended-release tablets): In large
doses this B vitamin (niacin) lowers
cholesterol and triglycerides. More
common side effects are flushing,
elevation of blood sugar and liver
injury.

Tricor (fenofibrate
capsules): works by promoting the
dissolution and elimination of fat
particles in the blood. Risk of
rhabdomyolysis is increased when
combined with statins. Taken with meals.

Zetia (ezetimibe): acts
by diminishing the absorption of dietary
cholesterol through the intestines. More
common side effects are: abdominal pain,
back pain, diarrhea, joint pain, and
sinusitis. Zetia is not recommended for
people with moderate to severe liver
disease, or for children under 10.

4) Bruce J, Rabkin E., Martin V.
Rhabdomyolysis associated with current us of
simvastatin and Nefazodone: Case report and
current review of the literature. Advanced
Studies in Medicine 2003; 3: 168-172.